# K162107: TPH Spectra+ Universal Composite Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Sep 27, 2016 after 60 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K083610 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 4.

## Indications for use
TPH Spectra® + Universal Composite Restorative is indicated for direct or indirect replacement of missing or deficient tooth structure in primary and permanent anterior and posterior teeth, e.g., 1. Direct anterior and posterior restorations (including occlusal surfaces) 2. Core build-ups 3. Splinting 4. Indirect restorations including inlays, onlays

Source page: https://510kreport.com/device/K162107
Methodology: https://510kreport.com/methodology